# FDA recall D-0719-2021

> **Aurobindo Pharma USA Inc.** · Class II · drug recall initiated 2021-07-07.

## Product

Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets,  Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05

## Reason for recall

Presence of Foreign Substance- Potential of metal contamination.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0719-2021
- **Recalling firm:** Aurobindo Pharma USA Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-07
- **Report date:** 2021-08-18
- **Termination date:** 2023-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0719-2021

## Citation

> AI Analytics. FDA recall D-0719-2021. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0719-2021. Source: US FDA. Licensed CC0.

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